Understanding avacopan for ANCA-associated vasculitis: trial results and re-adjudication

Avacopan is a targeted oral medication used to treat anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a group of rare disorders characterized by inflammation of the blood vessels. The phase 3 ADVOCATE clinical trial evaluated whether avacopan could effectively replace the traditional use of high-dose glucocorticoids (like prednisone) in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Following initial concerns regarding the 2019 primary endpoint adjudication process, an independent, blinded committee from the Duke Clinical Research Institute re-evaluated the trial data in 2026. This re-adjudication confirmed that avacopan remains a non-inferior treatment option compared to standard prednisone tapers for achieving and maintaining remission in patients with these conditions.

What is the clinical significance of the 2026 re-adjudication?

The 2026 re-adjudication was a critical step in verifying the reliability of the ADVOCATE trial's original findings regarding avacopan's efficacy. By re-evaluating the Birmingham Vasculitis Activity Score (BVAS), relapse rates, and remission status from weeks 26 through 52, independent experts confirmed that the initial conclusions were robust and not significantly skewed by the original adjudication methods. According to data published in 2026, the concordance between the 2019 and 2026 assessments was 95.2% for remission and 93.6% for sustained remission, indicating a very high level of consistency across both reviews.